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FDA Announces Long-Awaited Rule to Update Cigarette Warnings

Health Letter, March 2020

By Fiona Lynn

Image: fongbeerredhot/Shutterstock.com

After a delay of more than eight years that resulted in part from tobacco company litigation, the Food and Drug Administration (FDA) finally proposed a new rule that would require graphic warnings on cigarette packages and advertisements about the dangerous health consequences of smoking.

Currently in the U.S., approximately 34.3 million adults and 1.4 million adolescents (aged 12-17 years) smoke cigarettes, and smoking kills about 480,000 Americans every year, making it the leading cause of preventable disease and death in this country. This habit has persisted among millions of Americans despite the many well-documented and life-threatening risks posed by smoking, including heart disease, stroke, chronic obstructive pulmonary disease and many types of cancer.

For this reason, the U.S. federal government has for decades required warnings to appear on cigarette packaging and advertisements to highlight the dangers of smoking. The first warning labels appeared on cigarette packages in 1966 to warn consumers of the risks that cigarettes pose to their health. These warnings have not been updated since 1984, when the Surgeon General’s warning was added to them.

The lack of change in cigarette labels and advertisements has been a detriment to efforts to reduce the rates of smoking in the U.S. Evidence has shown that these 35-year-old warnings have little to no impact on consumers because the content is old and unmemorable, and the warnings are small and easy to ignore. These flaws have left much of the public oblivious to the serious risks of smoking.

TCA passage and lawsuit

In 2009, the federal government finally took up the task of revamping the warnings on cigarette packages and in advertisements for cigarettes to make them more effective. The Family Smoking Prevention and Tobacco Control Act (TCA) of 2009 was signed into law in part to update cigarette warning labels for the first time in 25 years. This legislation tasked the Food and Drug Administration (FDA) with regulating the tobacco industry, including creating new warning labels for cigarette packaging and advertisements.

The FDA made its first attempt at updating the warning labels in June 2011, when the agency issued a new rule calling for all cigarette packages to feature one of nine warning statements related to the negative health consequences of smoking, each of which would be accompanied by color graphics depicting these consequences. These eye-catching changes were supposed to make the warnings harder to ignore and, thus, more likely to prevent smoking.

However, a number of tobacco companies filed a lawsuit against the FDA claiming that the purpose of the new labels was not to inform consumers but to encourage a change in their behavior. In February 2012, the rule was declared unconstitutional by the U.S. Court of Appeals for the District of Columbia, which ruled that the proposed requirements for the new warnings were a violation of the tobacco companies’ First Amendment rights. In March 2013, the federal government announced that it would not appeal the decision to the Supreme Court.

The new FDA proposed rule

After the 2012 ruling, the FDA did extensive research to support the development of a new rule for graphic cigarette warning labels that would withstand legal challenge by tobacco companies. In 2016, because of agency delays, several public health groups, including the American Academy of Pediatrics, American Lung Association and Campaign for Tobacco-Free Kids, sued the FDA to compel the agency to issue the new rule. In March 2019, a federal judge in the U.S. District Court for the District of Massachusetts sided with the public health groups and ordered the FDA to publish a proposed rule by August 2019 and issue a final rule by March 2020.

In compliance with the judge’s order, the FDA in August 2019 published a proposed rule entitled “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements.” Under the requirements of the proposed rule, each cigarette package label and advertisement would have to contain one of 13 different warnings that combine text statements with photo-realistic color images, which tobacco companies must display equally and randomly on the cigarette packages and advertisements they produce, and which must be rotated on a quarterly basis.

The proposed warnings refer to some of the lesser-known, but serious health risks of smoking, such as bladder cancer, type 2 diabetes, erectile dysfunction, and stunted fetal growth in the fetuses of pregnant people who smoke. The warning labels would need to take up a significant amount of space and be displayed prominently: They would be required to occupy the top 50% of the front and back panels of cigarette packages and the top 20% of cigarette advertisements. These changes are designed to make the warnings more noticeable to consumers, who research shows have become inured to the current warnings.

The FDA’s research regarding this proposed rule shows that the new warnings would improve public understanding of the consequences of smoking.

The public comment period for the FDA’s proposed rule closed on Oct. 15, 2019.


Cigarette warnings have been long overdue for an update. The TCA started this process in 2009, 25 years after the most recent previous update. More than a decade later and facing a court-ordered deadline, the FDA has finally issued a proposed rule for new cigarette warnings. When finalized, the rule will dramatically overhaul the warnings, ensuring that new information about the dangers of smoking reaches consumers and makes them think twice about smoking.

The FDA is set to finalize the rule this month. The new requirements would take effect in 15 months — barring additional litigation by tobacco companies that could cause further delays.